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Taking people in ChinaPhase 4

Tests ShengXian-QuYu decoction in people with heart failure

Tests a herbal decoction against placebo in adults with heart failure.

Key facts

Who runs it
China-Japan Friendship Hospital
Where
Baoding, Beijing, Changji, Changzhi, Chengdu, Gongyi, Jining, Korla, Linhai, Qingdao, Qinhuangdao, Tianjin, Ürümqi, Xinyuan, Yangzhou, Yining, and Zhaosu, ChinaSee the 26 sites
Trial code
Registry title
SHengXIaN-QuYu DEcoction in Heart Failure With Reduced and Mildly Reduced Ejection Fraction
Status
Recruiting
Phase
Phase 4
People taking part
336 people, planned
Started
29 Mar 2023
Expected to end
31 Dec 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • ShengXian-QuYu Decoction
  • Placebo
Record updated
5 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with symptomatic heart failure and a weakened heart pump (LVEF under 50%). It tests ShengXian-QuYu Decoction against a placebo.

Age
18 years or older
Sex
Women and men can both join.
Disease stage
Symptomatic heart failure with reduced ejection fraction, NYHA class II-IV, with LVEF <50%.
Biomarker or test result
NT-proBNP >600 pg/ml or BNP ≥150 pg/ml. If hospitalized for heart failure in the previous 12 months: NT-proBNP ≥400 pg/ml or BNP ≥100 pg/ml.

Main reasons for not taking part

  • Acute decompensated heart failure, heart attack, stroke or heart surgery within 4 weeks before enrolment
  • Uncontrolled severe arrhythmia
  • Planned heart transplant or device implantation
  • Severe liver impairment, severe infection or eGFR <30 mL/min/1.73 m^2
  • Active cancer needing treatment, pregnancy or breast-feeding

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • Male or female, aged ≥18 years at the time of consent
  • Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV)
  • LVEF <50%
  • NT-proBNP >600 pg/ml or BNP ≥150 pg/ml (or if hospitalized for heart failure within the previous 12 months, NT-proBNP ≥400 pg/ml or BNP ≥100 pg/ml) at enrolment
  • Provision of signed informed consent prior to any study specific procedures

Who cannot take part

  • Current acute decompensated HF or hospitalization due to decompensated HF, ACS, stroke or transient ischemic attack (TIA), coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement, or other major cardiovascular surgery within 4 weeks prior to enrolment
  • Uncontrolled severe arrhythmia
  • Planned to undergo heart transplantation or device implantation
  • Severe infection
  • Active malignancy requiring treatment at the time of visit 1
  • Any condition outside the CV and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 1 years based on investigator's clinical judgement
  • Heart failure due to infiltrative cardiomyopathies(cardiac amyloidosis, etc.), fulminant myocarditis, constrictive pericarditis
  • Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
  • Hepatic impairment aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment)
  • eGFR <30 mL/min/1.73 m\^2 by CKD-EPI
  • Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding
  • Systolic blood pressure < 90 mmHg, or systolic blood pressure ≥ 180 mmHg, or diastolic blood pressure ≥ 110 mmHg on 2 consecutive measurements
  • Participation in another clinical study

Where in China

  • Tang County Hospital of Traditional Chinese MedicineBaoding, ChinaContact: Jianfei GuanTaking people
  • Beijing Changping Nankou HospitalBeijing, ChinaContact: Liling ZhengTaking people
  • Beijing Fengtai Hospital of Integrated Traditional Chinese and Western MedicineBeijing, ChinaContact: Lingling LiuTaking people
  • Changping District Traditional Chinese Medicine HospitalBeijing, ChinaContact: Zhao JinTaking people
  • China-Japan Friendship HospitalBeijing, ChinaContact: Jiang LiuTaking people
  • Dongcheng District First People's HospitalBeijing, ChinaContact: Hongyu FuTaking people
  • Dongfang Hospital Affiliated to Beijing University of Chinese MedicineBeijing, ChinaContact: Xiaoyun CuiTaking people
  • Huairou District Traditional Chinese Medicine Hospital of BeijingBeijing, ChinaContact: Shaojun ChenTaking people
  • Peking University People's HospitalBeijing, ChinaContact: Ding LiTaking people
  • Changji Hospital of Traditional Chinese MedicineChangji, ChinaContact: Liang GuiTaking people
  • Changzhi Hospital of Traditional Chinese MedicineChangzhi, ChinaContact: Meiling ShiTaking people
  • Changzhi Medical College Affiliated Heji HospitalChangzhi, ChinaContact: Xiaojian LiuTaking people
  • The Affiliated Hospital of Changzhi Institute of Traditional Chinese MedicineChangzhi, ChinaContact: Haijun SongTaking people
  • Chengdu Integrated TCM and Western Medicine HospitalChengdu, ChinaContact: Yao LiuTaking people
  • Gongyi City Public Hospital of TCMGongyi, ChinaContact: Jijie WangTaking people
  • Jining Hospital of Traditional Chinese MedicineJining, ChinaContact: Zhiyang ZhuTaking people
  • Korla Hospital of Traditional Chinese MedicineKorla, ChinaContact: Huiyun LiTaking people
  • Linhai Hospital of Traditional Chinese MedicineLinhai, ChinaContact: Yingjing SongTaking people
  • The Affiliated Hospital of Qingdao UniversityQingdao, ChinaContact: Hui XinTaking people
  • Funing Hospital of Traditional Chinese MedicineQinhuangdao, ChinaContact: Shi LiTaking people
  • Jixian Chinese Traditional HospitalTianjin, ChinaContact: Baolong YangTaking people
  • Urumqi Hospital of Traditional Chinese MedicineÜrümqi, ChinaContact: Palidan Wubu'erTaking people
  • Xinyuan Traditional Chinese Medicine HospitalXinyuan, ChinaContact: Weisheng MaoTaking people
  • Yangzhou Hospital of Traditional Chinese MedicineYangzhou, ChinaContact: Xiaobin WangTaking people
  • Gulja Hospital of Traditional Chinese MedicineYining, ChinaContact: Zhiyang ZhangTaking people
  • Zhaosu Hospital of Traditional Chinese MedicineZhaosu, ChinaContact: Chao ZhangTaking people

About the trial

What the trial wants to find out

The purpose of this study is to conduct a multicenter, randomized clinical trial to evaluate the effect of "ShengXian-QuYu Decoction" on quality of life , symptoms, and biomarkers in heart failure patients with reduced and mildly reduced ejection fraction.

The 2 groups in the trial

  • ShengXian-QuYu DecoctionExisting treatment, for comparison

    Patients will be randomized 1:1 to either ShengXian-QuYu Decoction or placebo. "ShengXian-QuYu Decoction" (calculated by a medicine): 30g of Astragalus membranaceus (Huangqi), 12g of Cornus officinalis (Shanzhuyu), 9g of Panax ginseng (Hongshen), 12g of Anemarrhena asphodeloides (Zhimu), 8g of Cimicifuga foetida (Shengma), 8g of Bupleurum chinense (Chaihu), 10g of Platycodon grandiflorum (Jiegeng), 10g of Sparganium stoloniferum (Sanleng), 9g of Curcuma phaeocaulis (Ezhu), 3g of Whitmania pigra (Shuizhi).

  • placeboPlacebo, for comparison

    Placebo matching ShengXian-QuYu Decoction

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effects of "ShengXian-QuYu Decoction" on Quality of Life, Symptoms, and Biomarkers in Heart Failure Patients With Reduced and Mildly Reduced Ejection Fraction: a Pragmatic, Nationwide, Multicenter, Parallel Group, Randomized, Double-Blind, Placebo-Controlled Trial
Plain-language title
Tests ShengXian-QuYu decoction in people with heart failureGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
5 November 2026